ULTRA Silver

Primary DI
20015961649704
Brand
ULTRA Silver
Company
MILLIKEN HEALTHCARE PDTS, LLC
Model
8"x20"
Catalog number
3000112212
Device description
ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ULTRA Silver dressings kill bacteria within the dressing and provides an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a polyester/ nylon wound contact layer coated with an ion-exchange silver, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with "Milliken" above and "ULTRA Silver" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.
Published
2021-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015961649707PackageGS12In Commercial Distribution
20015961649704PackageGS15In Commercial Distribution
00015961649700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001596164970710015961649707
2001596164970420015961649704
00015961649700000159616497000159616497000015961649700

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18004326686HealthcareCustomerService@Milliken.com

Regulatory Flags#

DUNS number
963905539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015961687078AGILE"4""x4"""30001172222021-02-04
00015961687085AGILE"2""x2"""30001199912021-02-04
00015961687092AGILE"Pre-cut 4""x4"""30001199922021-02-04
00015961687108AGILE"4""x10"""30001199932021-02-04
00015961293026ULTRA"4""x5"""30000068402021-01-06
00015961477952TRITEC"4""x5"""30000200402021-02-01
00015961477969TRITEC"4""x48"""30000200512021-02-01
00015961649717ULTRA"8""x20"""30001122212021-01-06
00015961650041TRITEC"Pre-Cut 4""x5"""30001128162021-02-01
00015961669197ULTRA Border "3""x3"""30001168772021-01-06
00015961669203ULTRA Border "4""x10"""30001168802021-01-06
00015961669210ULTRA Border "4""x4"""30001168782021-01-06
00015961669227ULTRA Border "6""x6"""30001168792021-01-06
10015961687075AGILE4"x4"30001172222021-02-04
10015961687082AGILE2"x2"30001199912021-02-04
10015961687099AGILEPre-cut 4"x4"30001199922021-02-04
10015961687105AGILE4"x10"30001199932021-02-04
00015961293002ASSIST Absorbent"24""x36"""30000046222021-02-02
00015961293019ASSIST Silver Absorbent"24""x36"""30000069642021-02-02
00015961464358ASSIST Silver"4""x48"""30000511752021-02-02

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